Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Wyeth

Status and phase: Completed; Phase 3

Conditions: Bacterial Pneumonia

Treatments: Drug: Tigecycline; Drug: Cilastatin; Drug: Imipenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080496

3074A1-311

Details and patient eligibility

About

To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age.
• Subjects known or suspected to have acute hospital-acquired pneumonia.

Exclusion criteria

• Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded)
• Suspected or known Legionella infection
• Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind